NDC 35418-136

Dilotab II

Acetaminophen Phenylephrine

Dilotab II is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Zee Medical Inc. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

Product ID35418-136_b5d329d7-c154-43d5-b26b-31f87a654012
NDC35418-136
Product TypeHuman Otc Drug
Proprietary NameDilotab II
Generic NameAcetaminophen Phenylephrine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-06-12
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameZee Medical Inc
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35418-136-68

50 CARTON in 1 CARTON (35418-136-68) > 125 PACKET in 1 CARTON (35418-136-67) > 2 TABLET in 1 PACKET (35418-136-02)
Marketing Start Date2012-06-12
Marketing End Date2024-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35418-136-67 [35418013667]

Dilotab II TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-136-02 [35418013602]

Dilotab II TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

NDC 35418-136-68 [35418013668]

Dilotab II TABLET
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:3569ede4-90b9-4ea0-991e-173ed8c4a82e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046378
  • 1300739
  • UPC Code
  • 0690689014872
  • NDC Crossover Matching brand name "Dilotab II" or generic name "Acetaminophen Phenylephrine"

    NDCBrand NameGeneric Name
    35418-136Dilotab IIAcetaminophen Phenylephrine
    42961-052Dilotab IIAcetaminophen Phenylephrine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.